Luis N Guedes MS, MSQA, CQA, CQE, CMQ/OE

SUMMARY

Seasoned Quality Assurance/Quality Control professional with over 30 years’ experience in the Medical Device, Biotechnology and Pharmaceutical Industries.

PROFESSIONAL EXPERIENCE

MOBILHELP

Regulatory Analyst Contract (4/2/2019-7/25/2019), Boca Raton, Fl

Provide regulatory an administrative support to assist the team in complying with 21 CFR Part 820.

Provide general oversight of the company's Quality Management System to ensure overall compliance with the regulations.

Nutriforce Nutritionals, Palm Beach Lakes, Fl

Supplier Quality Auditor (05/2017- 07/2018)

Managed all aspects of Nutriforce’s 3rd party audit of contract manufacturer’s, vendors and laboratories.

Programmed the audits and contacted supplier quality management to schedule the audits.

Prepared for audits by reviewing pertinent documentation.

Reported on minor, major and critical observations.

Prepared final reports for Vitamin Shoppe Corporate, or vendor’s quality management

Followed up on corrective action to ensure closure of the audits.

Started up the Quality Inspection Department in Avondale, Arizona.

Biomet 3i, Palm Beach Gardens, FL

Sr. Regulatory Compliance Specialist/Lead Auditor (11/2012 – 07/2014)

Managed all aspects of Biomet 3i Internal Quality System Audit Program to assess compliance with US and International Regulations and Quality System Standards ISO 13485:2003, 21CFR Part 820 and FDA Q.S.R.

Implemented line clearance procedures throughout manufacturing, receiving inspection and in–process testing.

Coached personnel on activities and training to maintain quality systems.

Participated in Plant Quality Progress reports.

Updated and maintained Work Instructions, Forms and manufacturing related documents.

Assisted in Management Review

Biomet 3i, Palm Beach, Fl

CAPA Engineer (11/2010-11/2012)

Managed the CAPA process to ensure that tasks occur within the timelines established by the procedure and meet

regulatory requirements.

Coached CAPA process owners on the correct implementation of CAPA’s

Prepared and presented web based CAPA training.

Ensured the effectiveness of CAPA’s.

Reviewed hundreds of SCARS (Supplier Corrective Action Requests) for adequacy of implementation and completeness of supplier corrective actions.

Participated in ongoing identification of quality indicators.

Led continuous quality system improvement efforts, including project schedules.

Biomet 3i, Palm Beach, Fl

Regulatory Compliance Specialist (5/200*-**-****)

Served as Company Internal Lead auditor.

Performed CAPA verification of effectiveness audits.

Provided CAPA training to operations personnel.

Provided companywide training on Good Documentation Practices.

Implemented regular walkthrough audits and reported on audit finding

Amgen Inc, West Greenwich, RI

Sr. QA Specialist (05/2006-10/2007)

Conducted QA oversight of the Enbrel Manufacturing Facility.

Provided guidance on GMP compliance requirements and risk assessments to QA Specialists and Sr. QA Associates.

Reviewed and approved CAPA's for closure.

Reviewed and approved standard operating procedures and process and equipment validation protocols.

CORDIS CORPORATION, Miami Lakes, Fl

Quality Assurance Auditor (04/2004-04/2006)

Provided auditing services in the area of compliance.

Reviewed Temporary Authorities, Recall Files and Validation Protocols.

Revised over 100 Receiving Inspection Protocols.

Managed a Corrective Action (CAPA) on the revision of Receiving Inspection Protocols.

NABI BIOPHARMACEUTICALS, Boca Raton, Fl

Sr. Quality Assurance Specialist (08/1998-04/2004)

Exercised Quality assurance over sight over the Nabi-HB contract Manufacturing Facility located in Winnipeg, Canada and the Boca Manufacturing Facility.

Conducted investigations into Deviation Reports, OOS’s, Nonconforming Material Reports and Failure Investigations.

Resolved issued with the introduction of a non-approved solvent/detergent into the purification are, which saved the company over 10 million dollars in lost sales.

EDUCATION

Master’s in chemistry

University of Puerto Rico

Master’s in science in Quality Assurance

Dominguez Hills University

CERTIFICATIONS

Certified Quality Auditor, Certification Number: 38179

Certified Quality Engineer, Certification Number: 63578

Certified Manager of Quality/Organizational Excellence, Certification Number: 53717

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